Manufacturing Standards. All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. Agreement No. Sort # Scaling Rule 97318 3 WS Average Log Length Preferred Log Lengths "WS" indicates that west side scaling rules apply. Minimum trim is 8 inches per scaling segment for west side scaling rules. "ES" indicates that east side scaling rules apply. Minimum trim is 4 inches per scaling segment for east side scaling rules. Poles produced under this contract will be manufactured to ANSI specifications (American National Standard Specifications and Dimensions for Wood Poles), in force at the time of signing this contract.
Manufacturing Standards. Pfizer shall manufacture and supply the Product in material accordance with the Specifications and cGMP. Such Specifications may be revised through written notification by Pfizer to Purchaser to conform to the Authorization or changes to the manufacturing or distribution of the Product.
Manufacturing Standards. All forest products except poles, produced and sold under this contract will be manufactured to maximize the amount of logs meeting preferred log lengths and to achieve the average log length listed. Agreement No. Sort # Scaling Rule 97790 7 WS Average Log Length Preferred Log Lengths
Manufacturing Standards. The Good Manufacturing Practice Regulations (GMP) (21 C.F.R. Part 820) will be the standard to be applied for manufacturing, processing, packaging, storage and delivery of this product. If at any time during the life of the Contract, the Contractor fails to comply with GMP in the manufacturing, processing, packaging, storage, stability and other testing of the manufactured drug substance or product and delivery of this product and such failure results in a material adverse effect on the safety, purity or potency of the product (a material failure) as identified by the FDA, the Contractor shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If, within the thirty (30) calendar day period, the Contractor fails to take such an action to the satisfaction of the Government Project Officer/COR, or fails to provide a remediation plan that is acceptable to the COR, then the Contract may be terminated.
Manufacturing Standards. Manufacturer shall manufacture and supply each Product (including disposing of all Waste and other materials) in accordance with all applicable Specifications, applicable Laws, requirements under the applicable Quality Agreement, and this Agreement.
Manufacturing Standards. The Current Good Manufacturing Practice Regulations (cGMP) (21 CFR Parts 210-211) will be the standard to be applied for manufacturing, processing and packing of this therapeutic product. If at any time during the life of the contract, the Offeror fails to comply with cGMP in the manufacturing, processing and packaging of this therapeutic product and such failure results in a material adverse effect on the safety, purity or potency of this therapeutic product (a material failure) as identified by CBER and CDER, the Offeror shall have thirty (30) calendar days from the time such material failure is identified to cure such material failure. If the Offeror fails to take such an action within the thirty (30) calendar day period, then the contract may be terminated.
Manufacturing Standards. Licensee shall manufacture any Licensed Goods and Services in a manner that is consistent with Quality Standards, including as to the design and quality of the Licensed Goods and Services.
Manufacturing Standards. Hospira shall manufacture Product in accordance with the Product Specifications. The parties may amend the Product Specifications from time to time by written agreement without amending this Agreement.
Manufacturing Standards. IVEMSA shall not be obligated to, nor be liable for the quality and design contained in the manufacturing information. Therefore, it should be the express responsibility of MASIMO to establish guidelines and policies to provide for quality control. MASIMO shall have the right to free access to the plant and offices of IVEMSA precisely at the site where the operation for MASIMO is conducted, at all times during working hours, for the purpose of reviewing the manufacturing and production facilities and the manufacturing methods being employed by IVEMSA in the manufacturing of the products. STORAGE FACILITIES AND DELIVERY OF COMPLETED PRODUCTS.- IVEMSA, without being obligated to, shall reasonably assist MASIMO in securing and maintaining adequate facilities for all raw material received from MASIMO as well as work in progress and completed products in such manner as to prevent loss or damage of any kind of raw materials, work in progress and completed products. IVEMSA shall also further assist MASIMO in maintaining adequate records of the same, including inventory, work in progress, completed products and any other records and reports reasonably required by MASIMO. Delivery of completed products shall be made by IVEMSA to MASIMO or its designee at such time and place with such carriers as may be designated by MASIMO and in accordance with shipping instructions received from the latter. IVEMSA agrees to adhere to all shipping and handling procedures requested by MASIMO for which the latter shall prepare forms and operating procedures to be furnished by MASIMO.
Manufacturing Standards. Hospira will manufacture, package, and label the Product in accordance with the Product Specifications, cGMP and all Applicable Laws, as then in effect. The parties agree that, should Theravance wish to implement any amendment to the Product Specifications, Theravance shall provide written notice thereof to Hospira for Hospira’s review and approval, which approval shall not be unreasonably withheld. Each party further agrees promptly to notify the other of any new instructions or changes to the Product Specifications required by the FDA or Applicable Laws and shall confer with each other with respect to the best means to comply with such instructions or change requirements.
